Encore Medical, LP Recalls Reverse Shoulder Prosthesis Humeral Socket Inserts Due to Incorrect Labeling
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Encore Medical, LP has issued a voluntary recall for 20 Reverse Shoulder Prosthesis (RSP) humeral socket inserts because the implants contain incorrect labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Encore Medical, LP has initiated a voluntary recall of specific Reverse Shoulder Prosthesis (RSP) humeral socket inserts. The recall was triggered after it was discovered that certain knee and humeral socket implants were distributed with incorrect labeling. The FDA has classified this as a Class II recall.
Which Products Are Affected
The recall involves 20 units of the following medical device:
- Brand Name: Reverse Shoulder Prosthesis (RSP)
- Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus
- Model/Catalog Number: 509-00-432
- Lot Code: 385P1263
- GTIN: 00888912144575
These products were distributed to healthcare facilities in the following states: VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What You Should Do
Encore Medical, LP notified affected customers via a formal letter initiated on January 15, 2026. Healthcare providers and facilities should check their inventory for the specific lot code (385P1263) and follow the instructions provided in the firm's notification letter regarding the return or quarantine of the affected implants. For additional information, parties may contact Encore Medical, LP at their Austin, Texas location.
Why This Matters
Incorrect labeling on medical implants like the Reverse Shoulder Prosthesis can lead to the selection of improper components during surgery. This poses a risk to patient safety and may impact the success of the prosthetic procedure.
Source
Original source: FDA Official Notice ↗
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